Obsolete Document Retention Requirements
How long does ISO 9001/13485 obligate a company to retain hard copies of approved/released documents that have become obsolete?
For example, Revisions 01 and 02 of a certain document have been replaced by Rev. 03. How long (if at all) do we need to keep/save obsolete hard copies of Rev. 01 and Rev. 02?
Clause 4.2.3.1 of ISO 14969 says that a company needs to “ensure prompt withdrawal of obsolete copies of controlled documents”. Does this mean that we no longer need to retain hard copies of the approved/released obsolete documents, or is it sufficient to simply remove them; of course, we will retain the soft copies.
Thanks a lot.
Asherlee
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